Medical Devices
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Canadians rely on a diverse range of medical devices to
diagnose, prevent, or treat a disease, disability, or physical
condition. Products such as dialysis equipment, pacemakers, and
baby incubators have improved or saved the lives of many. Other
medical devices such as medical gloves, syringes, X-ray
equipment, and surgical lasers are indispensable to today's health
care practitioners.
Health Canada, through its Health Products and Food Branch
(HPFB), is responsible for medical devices in Canada. HPFB
monitors and evaluates the safety, efficacy and quality of
diagnostic and therapeutic medical devices, so that consumers
and health care professionals can use them with confidence.
Minimizing risk, maximizing safety
Recent advances in technology and health research are
contributing to the rapid development of new medical devices.
HPFB works to balance the risks associated with any new health
science innovation with the benefits that medical devices can
provide to Canadians.
All medical devices in Canada are subject to the Food and
Drugs Act and its regulations.
Medical devices are categorized into four classes based on the
level of risk associated with their use. Class I devices present the
lowest potential risk (e.g. thermometers) and Class IV devices
present the greatest potential risk (e.g. pacemakers). Class II, III,
and IV devices receive increasingly rigorous reviews, and must
be licensed before being sold in Canada. Class I devices do not
require licenses, but manufacturers must ensure that devices are
designed and manufactured to be safe, as required by the Medical
Devices Regulations.
The Special Access Programme (SAP) allows health care
professionals to gain access to medical devices that have not yet
been approved for sale in Canada. Special access can be
requested for emergency use or if conventional therapies have
failed, are unavailable or are unsuitable to treat a patient. The
authorization permits the importation or sale of unlicensed
medical devices and Class III and IV custom-made medical
devices.
Medical Devices Bureau
Class III and IV medical devices, whether they are
manufactured in Canada or abroad, are carefully reviewed before
being authorized for sale in Canada. The Medical Devices
Bureau, part of the Therapeutic Products Directorate in HPFB,
does this work.
The Medical Devices Bureau also works closely with the
HPFB Inspectorate to monitor approved medical devices for
compliance with Canadian medical devices regulations and
Health Canada guidelines, after they become available on the
Canadian market. If a medical device's safety or its effectiveness
comes into question, the manufacturer may be required to recall
or refit the device. If necessary, the Bureau will suspend a
product's license.
Our commitment to Canadians
Health Canada's priority is the continued health and safety of
Canadians. Through its ongoing efforts, Canadians can have full
confidence in the medical devices they have come to depend on.
Health Canada
Health Products and Food Branch
250 Lanark Avenue
Graham Spry Building
Address Locator: 2005A
Ottawa ON K1A 0K9
Telephone: (613) 957-1806
Fax: (613) 954-3957
Email: hpfb-dgpsa@hc-sc.gc.ca
Website: www.healthcanada.gc.ca/hpfb
Therapeutic Products Directorate
Medical Devices Bureau Building 3, Tunney's Pasture Address Locator: 0301H1 Ottawa ON K1A 0K9 Telephone: (613) 957-1909 Fax: (613) 957-6345 Email: device_licensing@hc-sc.gc.ca Website: www.healthcanada.gc.ca/medicaldevices
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